Persistent supply chain constraints and a lack of comparative data are holding back the U.S. coronavirus testing response, a pair of public health officials outlined Friday in an update on a federal government initiative to speed new testing technologies to market.
Rick Bright, who transitioned to the National Institutes of Health after being removed by the Trump administration as director of medical countermeasures organization BARDA, and Rachael Fleurence, now at NIH after leading medical device real-world evidence group NESTcc, spelled out the program's goals and obstacles during an NIH webinar on Friday.
As of the start of September, the Rapid Acceleration of Diagnostics (RADx) initiative had spent about $400 million of the $1.5 billion in federal funds allotted when it was formed at the end of April. The program is aimed at getting the right tests to the right people at the right time, and making sure underserved populations aren't being left out.
So far, 16 companies (nine high-throughput labs and seven point-of-care test companies) including Illumina, Mammoth Biosciences and Fluidigm have received funds; a first round of awardees was announced at the end of July, and a second at the beginning of this month.
Awards range in size from $1,390 to Lincoln, Nebraska-based biotech MatMaCorp — for a "portable mini-lab that can rapidly perform multiple RT-PCR assays in a single platform," designed for healthcare settings in underserved, rural populations — to $71,000 for Quidel, to help the medtech scale manufacturing for its point-of-care, quick-turnaround coronavirus antigen and combo flu tests.
Bright and Fleurence were among the authors, along with NIH Director Francis Collins, of a New England Journal of Medicine report earlier this month outlining RADx.
On Friday, they laid out key regulatory, logistics, electronic data and reimbursement "areas to watch" in COVID-19 testing, including the matching of test data to EHRs to generate real-world evidence for research and surveillance and the gray area on whether general screening tests are covered by insurance. Within the next month or two, they hope to see regulatory progress on an at-home or over-the-counter test particularly for asymptomatic or pre-symptomatic testing.
Matching adequate tips, reagents, pipettes and swabs to labs in need remains a challenge, Bright highlighted in remarks.
"We are almost in October — seven to eight months into this pandemic — and believe it or not, we still have significant supply chain challenges in our country," Bright said. "We have some of these incredible technologies that have been supported and manufactured in the millions ... today sitting in warehouses because we don't have enough swabs to couple with those tests," he added.
It does come down to tips and swabs.
Rick Bright
Senior Adviser to the NIH Director
But on a more optimistic note, Bright said gains in technology, data reporting and regulatory and reimbursement logistics "are going to lay a foundational footprint to put us all in a better place for the next outbreak,” which may also apply to non-pandemic emerging infectious diseases and seasonal flu.
Fleurence, on the other hand, focused on areas "ripe for empirical evidence generation" including pool testing, and comparing performance of different testing modalities, sample collection protocols and frequency of testing.
She also expressed interest in marrying some of CDRH's work on incorporating patient preference information into the regulatory process for tests.
"There's going to be evidence that some populations will trade off the lower sensitivity to be able to do higher frequency testing at lower costs to be able to get back to school. I think these are all open questions I don't have the answer to it but I think it's interesting to think about including that patient preference world [in] the world of diagnostic testing."
